PharmaTrackBatch traceability ERP
21 CFR Part 11 · Schedule M

Every batch traceable, every signature provable.

PharmaTrack links raw material to finished pack across the whole manufacturing floor — goods receipt, batch genealogy, QA release, GS1 serialization, packaging-line scanning and dispatch — behind an audit trail the database itself will not let anyone edit.

Immutable audit trail ALCOA+ data integrity GS1 DataMatrix & QR eBMR Multi-plant, multi-company
The platform

Three screens that carry the compliance weight

The rest of the system supports these. Each one refuses to let the next step start until the previous one is genuinely complete — and the refusal comes from the database, not from a disabled button.

Screen one

Raw material & batch linking

Goods receipt through to batch genealogy, with the release gate that decides whether anything downstream may happen at all.

  • Vendor, GRN, COA and retest dates on every lot
  • Material issued to a batch, quantity reconciled
  • No QA release signature, no serialization — enforced
Screen two

Dynamic 2D & QR generator

Randomised, non-sequential serials — one per saleable unit — each carrying a complete GS1 element string, up to 500,000 in a single run.

  • AI (01) GTIN, (11) mfg, (17) expiry, (10) lot, (21) serial
  • GS1 DataMatrix for print, QR preview for on-screen check
  • Serial numbers are permanent and never reissued
Screen three

Packaging line integration

Handheld and fixed scanners verify the printed symbol against the record before a pack is allowed to move, with an e-signature gate on every label export.

  • Scan-to-verify, with mismatches blocked at the line
  • Label files released only against a signed authorisation
  • Short-lived export tokens, single use
Built for the inspection, not the demo

Compliance enforced where it cannot be bypassed

Controls that live in the user interface can be worked around by anyone who reaches the database. In PharmaTrack the rules are in the database — so the same answer comes back whether the request arrives from a screen, a report or a query window.

An audit trail nobody can editAppend-only by construction. Update, delete and truncate are refused for every role, and each row is hash-chained to the one before it, so a removed or altered entry breaks the chain visibly.
Electronic signatures per 21 CFR 11.50Two components — user ID plus password or signing PIN. Each signature records the signer, the date and time, and the meaning of the signing, and is bound to the exact record it approved.
A signature that stops meaning yesChange the record after it was approved and the signature is invalidated automatically. Re-approval is a new signature, and both remain visible in the history.
Enforced sequencing of steps — 11.10(f)Serialization is refused for a batch with no live QA release. Export is refused without a signed authorisation. The order of operations is a database rule, not a screen flow.
Five access levels, isolated by plantSoftware admin, company admin, plant head, QA/QC manager and store or production operator. A user cannot see another company's data or another plant's batches, and that boundary is applied at the data layer.
ALCOA+ and a complete eBMRAttributable, legible, contemporaneous, original and accurate — with the electronic batch manufacturing record reconstructable for any batch, and every scanned code traceable back to its raw materials.
Who it is for

Regulated manufacturing, wherever a lot number matters

PharmaTrack was built for pharmaceutical formulations, and the same chain of custody applies anywhere a finished pack has to be traced back to the materials that made it.

Pharmaceutical formulations API & bulk drugs Nutraceuticals & supplements Ayurvedic & herbal Veterinary medicines Cosmetics & personal care Medical devices Food & beverage processing Agrochemicals Contract manufacturing (CMO / CDMO)
Questions we are asked first

Before you book a call

Is PharmaTrack 21 CFR Part 11 compliant?

The software provides the technical controls Part 11 requires: an append-only audit trail, dual-component electronic signatures with the 11.50 manifestation, signature-to-record binding with automatic invalidation on change, enforced sequencing of steps, and access controls applied at the data layer. Compliance itself is a property of your validated installation and your procedures — the software is what makes it achievable, and it is built to be validated.

Does it meet Schedule M requirements?

Schedule M of the Drugs and Cosmetics Rules requires batch records, material traceability, and documented quality control decisions that survive review. PharmaTrack keeps the electronic batch manufacturing record, the material genealogy behind it and the QA release decision in one place, so a batch record can be reconstructed in full rather than assembled from separate files.

Can we run several plants and several companies?

Yes. The structure is many companies, each with many plants, one administrator per company, and users scoped to the plants they work in. The scoping is enforced in the database, so a report, an export and a screen all return the same rows for the same user.

What symbology do the labels use?

GS1 DataMatrix is the default for printed labels, which is what most pharmaceutical lines and regulators expect, with QR available and the identical payload either way. Labels are produced by the printer from a ZPL or TSPL template; the on-screen symbol is a preview the line can scan to confirm the payload before committing to a print run.

Will it work with our existing accounting system?

There is an integration path for Tally and for legacy ERP systems, so masters and transactions do not have to be maintained twice. Tell us what you run and we will tell you honestly what it will take.

How do we see it working?

Message us on WhatsApp at +91 62629 59501 or email info@ycsin.com and we will walk you through a live batch — receipt to serialized pack — on your own product structure.

Talk to us

Tell us what your floor actually does

We would rather understand your process than pitch at you. A short call is usually enough to say whether PharmaTrack fits — and if it does not, we will say so.

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